Job Description

Solid experience in a few of the area's listed below is needed to succeed in this role:

• LCMS
• Bioanalysis
• Small molecule and/ or large molecule
• Oligonucleotides
• Protein peptides- quantitative experience
• GxP including GOP & GCP
• Method development & sample analysis using LCMS

Responsibilities:

· Prepare reagents, standards, and control samples

· Analyze samples using various techniques specific to department

· Perform complex method development with limited supervision

· Perform method validation or qualification

· Operate analytical equipment

· Lead troubleshooting activities; assays and equipment

· Maintain analytical equipment

· Review, evaluate, and interpret data results

· Draft and present posters/presentations

· Train and mentor lower level Scientists

· Collaborate with clients and vendors

· Ensure lab area is clean and inspection ready at all times

· Remove lab waste

· Record tasks in accordance with Good Documentation Practices (GDP)

· Understand and apply regulatory requirements; GLP, GCP, 21CFR Part 11

· Follow applicable SOPs and procedural documents

· Other tasks as assigned

Qualifications & Education:

• BA/BS or higher with 5 years experience working LCMS at a CRO or pharma/ life sciences company
• PhD in relevant field with two years experience working in LCMS at a CRO or pharma/ life sciences company
• Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to independently perform complex lab work
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document clearly
• Knowledge of and experience in a regulatory environment

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